Saturn 9000
510(k) K063710
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063710 | Date16 Jul 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Saturn 9000 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed to capture and convert X-ray radiation into digital images. It functions as a high-resolution detector within radiology systems, enabling real-time digital radiography for general diagnostic imaging purposes, excluding mammography.
This device interfaces with traditional X-ray generators to produce digital X-ray images, facilitating integration into existing radiology workflows. Supplied as a reusable medical device, it is intended for use in clinical settings such as hospitals and diagnostic imaging centers. The Saturn 9000 holds FDA 510(k) clearance under the Radiology advisory committee, classified as a Class II device under regulation 21 CFR 892.1680. No third-party review was required.
Other devices from New Medical Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of medical facilities can use the Saturn 9000, and how does it integrate with existing systems?
The Saturn 9000 is designed for use in clinical settings like hospitals and diagnostic imaging centers. It functions as a high-resolution digital imager that interfaces with traditional X-ray generators, enabling seamless integration into existing radiology workflows. This means it can replace older film-based systems while maintaining compatibility with current equipment.
Is the Saturn 9000 a single-use or reusable device, and what does that mean for maintenance?
The Saturn 9000 is explicitly described as a reusable medical device. This means it is built for repeated use in clinical settings, requiring proper cleaning, sterilization, and maintenance protocols to ensure performance, safety, and longevity. Reusability also reduces waste compared to single-use alternatives.
What regulatory pathway was followed for FDA clearance of the Saturn 9000, and what does that imply for its safety and equivalence?
The Saturn 9000 received FDA clearance through a 510(k) submission, classified as substantially equivalent under the Radiology advisory committee (RA). This pathway demonstrates that the device met FDA standards for safety and performance by showing equivalence to a legally marketed predicate device. The clearance was granted under 21 CFR 892.1680, confirming its classification as a Class II device.
Are there different sizes or models of the Saturn 9000, and if so, how would a buyer determine which one fits their needs?
The provided data does not specify distinct sizes or models of the Saturn 9000 beyond its core function as a Solid State X-Ray Imager (Flat Panel/Digital Imager). However, the device’s compatibility with traditional X-ray generators suggests it may offer flexibility in field-of-view or resolution settings. Buyers should consult New Medical Co., Ltd. for detailed specifications on available configurations or customization options to match their imaging requirements.